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The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
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Could an overly burdensome QMS be the organization’s own doing?
Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...
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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...
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Speed meets precision for high-density components
ZEISS METROTOM 800 320 kV.
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PMS, Vigilance and Risk Management
Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Un...
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Shaping the Future of Metrology – Live in Your Region
Insights into our event series.
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Shaping regulatory complexity into strategic clarity
As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the success of the AI Act e-tool and the Data A...
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Plug and play dräneringslösningar
En universalkoppling är en anordning som du placerar i din rörledning, och som ger dig friheten att enkelt och snabbt renovera och byta ut ångfällor. Detta mins...
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Experience innovations of the future
ZEISS QUALITY INNOVATIONS WORLDWIDE event in Oberkochen, Germany, January 20-21, 2026.
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Press Release
PharmaRelations appoints Niels Buch Leander as new Chief Digital Officer and Executive Vice President Denmark.
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Sneak Peek of ZEISS Metrology Expert Tips Season 2
The second season of the video series starts in January 2026, but you can discover more about the highlights of Season 2 now.
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Advanced workflow automation and scalable image analysis in spatial biology
ZEISS and Concept Life Sciences announce partnership.
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FDA’s new CSA guidance: transforming software validation for production and quality systems
FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.
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Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
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Strategic Clarity: The New Currency in Life Science
In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, ...
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IVDR Reality Check: Are We Moving Fast Enough?
As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...
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Medical Plastics Tips & Tricks
Measuringhero video by ZEISS.
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Join our measuringhero Jay on the innovation tour
Experience our latest innovation from the Control fair.
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How to Assure Quality within R&D Medical Devices
Free webinar on June 3rd, 2025, 9:00 - 9:45 AM CEST and 5:00 - 5:45 PM CEST.
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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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The Future of Metrology is Coming to Your Region
Join our event series.
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ZEISS Hosts an exceptional Global Conference on Innovation and Production in Berlin
More than 50 distinguished speakers from leading manufacturing companies.
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New version of ISO 10993-1: the core standard for the biological evaluation of medical devices
ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...
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ZEISS Smartzoom 100 for Inspection Efficiency
Catch up on our free webinar.
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